510(k) DEN200043
- Device
- FilmArray Global Fever Panel
- Applicant
- Biofire Defense, LLC
- 510(k) number
- DEN200043
- Product code
- QMV
- Decision
- Unknown (DENG)
- Decision date
- 2020-11-20
- Date received
- 2020-06-26
- Regulation
- 866.3966
- Classification name
- Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Cynthia Phillips
- Address
- 79 W 4500 S Suite 14 Salt Lake City UT US 84107 84107
FDA Registration Numbers#
- 3002773840
- 3010770794
Source Documents#
510(k) summary PDF not indicated by FDA